Zdrowie i gospodarka · 28/10/2009

FDA Releases Draft Revised Guidance on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers

The Food and Drug Administration (FDA) has released a draft revised guidance for industry and reviewers on the Structured Product Labeling standard for content of labeling technical questions and answers. The guidance aims to assist sponsors in submitting product labeling information electronically and to provide information to FDA staff who review and manage that information using electronic systems.